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Jul25

Condoms: isn’t it about time that the government and health care providers were honest with us so that we can make informed choices about our bodies?

Tuesday, 25 July 2017 Written by // T.J. Miller Categories // Social Media, Gay Men, General Health, Research, Sexual Health, Health, International , Media, Opinion Pieces, Revolving Door, Guest Authors

What if condoms are not nearly as effective as we thought at preventing the transmission of STI’s? T. J. Miller reports on two research studies which say just that.

Condoms: isn’t it about time that the government and health care providers were honest with us so that we can make informed choices about our bodies?

To continue off of a theme that I started in my first article, I had referenced a story that was published in the New York Times on July 3, 1981 by Lawrence Altman, that spoke about clusters of Kaposi’s Sarcoma that had been diagnosed in gay men in the San Francisco and New York City area. This was the first reference that we would see in the mainstream media of what was to become the HIV/AIDS crisis.

Scientists, researchers and health care providers were challenged in not only coming up with effective medications for fighting this illness, but also a prevention program to keep the epidemic from spreading and thus the “safer sex” program was launched. However have government regulators and medical experts been giving the public accurate information about how effective condoms are? Have we as health care consumers and consenting adults been allowed to make accurate decisions about our bodies and what we choose to do (or not do) with them as a result? Let’s explore a few items that are based in fact.

What is the general definition of safer sex? Good question! That really depends on who you ask, on what given day you ask them, what phase the moon is in and where that particular agency is obtaining their funding from at the particular moment you ask the question. No, sadly this is not my idea of a sick joke. It is absolutely true. Safer sex parameters are influenced not only by science but by money.

As an example, in the United States Federal Budget we have in the past placed restrictions on some of our international HIV/AIDS educational programs that stressed abstinence only educational programs over other more traditional sexual health based programs, even though it has been proven repeatedly that these abstinence based types of programs do not work.

So now that we have discussed the funding issue and if you will be given accurate information due to who is paying the bill, the first part of safer sex is testing. Most programs agree that safer sex starts off with testing to determine if you have any Sexually Transmittable Illnesses (STIs). A generally agreed upon list on STI’s includes the following: Campylobacter, Chlamydia, Gonorrhea, Syphilis, HIV, Herpes, Human Papilloma Virus/Genital Warts, Hepatitis B, Hepatitis C, Pubic Lice, Scabies, Shigella and Tricomoniasis.

The goal of testing is to get the patient into treatment for any STI’s that they may have that have a cure, or into long term treatment for those that are manageable. It also is to provide education so that the patient can learn how to not spread their manageable STI to their sexual partners in the future. We will get back to this thought a little later on in the article.

The general thought in all safer sex programs has been based around one central theme. If there is any risk of bodily fluid transmission (pre-cum, semen or vaginal fluids) or you are having oral sex that involves the mouth touching a penis, a vagina or a rectum then a condom (male or female variety) or a dental dam must be used. This has been the gold standard since the mid 1980’s.

Now, with the advent of Pre-Exposure Prophylaxis (PrEP), Post Exposure Prophylaxis (PEP) and Treatment as Prevention (TasP) in the world of HIV care I have decided to take a second look at condoms and just how effective they are. This second look is also based upon the revelation that for years the medical community has been withholding information from the general public about the fact that individuals who have an undetectable viral load for six months or greater are unable to pass on the HIV virus through sexual contact.

Not only does this information impact the areas of Sexually Transmittable Illness prevention, it also touches on family planning issues and HIV/STI criminalization issues. What if condoms are not nearly as effective as we thought at preventing the transmission of STI’s? What if you have the proper conversation with a sexual partner and disclose your STI, have sex with them and then they still get the STI even though a condom is used? And what if that person then decides they are angry with you for passing your illness on and calls the police? It now becomes your word against theirs.

Think it couldn’t happen to you? Well the numbers I am about to present from two different studies done ten years apart by researchers at two well respected universities might just change your mind.

In order to understand the importance of these two studies we have to set a few facts and understand a few ground rules.

Fact number one: No government agency in the United States, Canada, Europe or anywhere else in the world has ever certified condoms for use in anal sex. They are regulated as a method of birth control, and as such they are tested for that use and certified for that use.

Numerous other articles have been published about this fact, but just to make sure, I contacted the U.S. Food and Drug Administration and they referred me to a February 10, 1987 statement made by then Surgeon General of the United States Dr. C. Everett Koop before the Committee on Energy and Commerce of the U.S. House of Representatives.

In his statement Dr. Koop states that condoms have not been tested by the FDA, but that they have been tested in outside studies as to their ability to stop the transmission of the HIV virus.

Fact number two: Every condom study that has been performed that I can locate in scientific literature, medical libraries and utilizing online resources, except for the two that I am relying on for this article, use observational data rather than measureable/quantitative data.

This means that the scientists that have published studies in these other studies did not use the actual product in real life situations OR they asked their test subjects to give the scientists their data after the event occurred, to the best of their recollection.

In other words, most of the studies tested condoms on mechanical devices that simulated sexual activities (mannequins) or their method of collecting data from human test subjects was to have their subjects fill out forms after they used the product, sometimes days/weeks/months after they used the product, or in the case of several studies where a test subject had a diagnosis of a sexually transmitted illness they had the client fill out the data form after the client was initially diagnosed.

“Mr. Smith/Ms. Jones we just diagnosed you with herpes, can you tell us what kind of condoms you used and how they worked?” Do you think that the data that they collected might have been a bit skewed by the anger or frustration that the patient might have been feeling at that particular moment?

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The first study I am going to reference is located here(1). It is a fantastic study that was done by a group from the Centers for Disease Control, the University of Alabama at Birmingham and the HIV Vaccines Trial Network in Seattle Washington.

In this study a group of 108 participants was enrolled. They were all STI free for six months prior to entering the study. They were taught by their physicians and nurse practitioners how to collect vaginal swabs pre-sexual activity and post-sexual activity so that the swabs could be tested for the presence of Prostate Specific Antigen (PSA). Women do not have PSA in their systems and do not produce PSA, so the scientists determined that the presence of PSA would demonstrate that there had been a transmission of bodily fluids from the male partner to the female partner during sexual activity.

In addition, the collection kit had a collection system for the condom (male or female variety) to be collected so that the researchers could examine the condom to see if the device had torn, broken or had any holes/microscopic tears in it.

At the end of the study these were the results. The male condom had a total effective protection rate of 20.3%. In other words the male condom allowed there to be a transmission of body fluids between partners for a variety of reasons about 8 out of 10 times. The female condom was successful 48.5% of the time. That translates to just about a 5 times out of 10 uses bodily fluid transmission rate. Again all of this data is for the Study that was accepted for publication in the American Journal of Epidemiology on January 3, 2007.

The second study that I am in possession of is an embargoed copy of uses the same testing protocol, but it measures the presence of PSA in both vaginal and rectal swabs collected from a study group of 229 subjects. I am not able at this time to name the researchers or the university that they are affiliated with because of the embargo.

This embargo is in place because the lead researcher is awaiting clearance from his funding source for me to be able to publish this study. Once clearance has been given for me to publish the full project I will amend this article and add the full text of the study.

Again, all participants of this 2016 study were STI free for six months prior to the study commencement and their full informed consent was given. Both studies were monitored by peer review boards and institutional ethics committees.

This second study had 118 heterosexual women and 111 gay men enrolled. As in the earlier study all of the participants were taught how to take either vaginal or rectal swabs to screen for the presence of PSA pre-sexual activity and again post-sexual activity. As in the earlier study the condoms were also collected and examined to check for device failure if a positive PSA test was found.

The failure rate for male condoms with the heterosexual women was 78% and it was 80% with gay men. The failure rate of the female condom in the heterosexual women in this study was MUCH higher at 73%. The female condom was not distributed to the gay male participants in this study.

So what do these studies tell us? I think the elephant in the room is that condoms are not as effective in the prevention of the transmission of body fluids as we have all been taught.

With failure rates this high, maybe the public health community needs to take a look at re-educating everyone on the proper use of condoms so that we can prevent the human errors that cause device failure, but also I think we also really need to get serious about other options.

PrEP, PEP, TasP and reducing stigma about all sexually transmitted illnesses are all very important parts of this conversation.

Another key component is that it is about time that our primary care providers, family doctors and OB/GYN’s all be taken to task over their utter failure to have these talks with their patients. I think that if we are going to have a total quality improvement compensation program tied to patient outcomes, then we need to have honest discussions about sexual health and not the bullcrap, warm and fuzzy talks that these providers have been having with patients. Honest, blunt and at times uncomfortable discussions with each and every patient need to occur.

We also need to be conducting STI screenings just like we test for blood glucose levels, cholesterol and other routine screenings.

Finally, I leave you with this question: This data has been out there for at least ten years, at least with the first study. Let me state that I am not an advocate of bareback sex. I actually take the stance that the choice to use a condom or not is to be made between the individuals who are involved in the intimate act after informed consent. How can someone give informed consent when they haven’t been given accurate information for all of these years?

(1) Maurizio Macaluso, Richard Blackwell, Denise J. Jamieson, Andrzej Kulczycki, Michael P. Chen, Rachel Akers, Dhong-jin Kim, Ann Duerr; Efficacy of the Male Latex Condom and of the Female Polyurethane Condom as Barriers to Semen during Intercourse: A Randomized Clinical Trial. Am J Epidemiol 2007; 166 (1): 88-96. doi: 10.1093/aje/kwm046

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